DrugPatentWatch Database Preview
QSYMIA Drug Profile
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When do Qsymia patents expire, and when can generic versions of Qsymia launch?
Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has sixty patent family members in seventeen countries.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
Summary for QSYMIA
| International Patents: | 60 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 8 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for QSYMIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QSYMIA |
| DailyMed Link: | QSYMIA at DailyMed |
Generic Entry Opportunity Date for QSYMIA
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for QSYMIA
| Drug Class | Sympathomimetic Amine Anorectic |
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity |
US Patents and Regulatory Information for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | ➤ Sign Up | ➤ Sign Up |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | ➤ Sign Up | ➤ Sign Up |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for QSYMIA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Extended-release Capsules | 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for QSYMIA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,802,636 | Combination therapy for treatment of sleep apnea | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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